Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
NCT ID: NCT01489449
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2012-12-31
2022-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stent
Stent Implantation (DES or BMS), no further treatment
Stent
bare metal stent implantation, any bare metal stent is allowed from different companies
DCB
"DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection
SeQuent(R) Please coated balloon
Angioplasty with Drug coated balloon (DCB)
Interventions
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Stent
bare metal stent implantation, any bare metal stent is allowed from different companies
SeQuent(R) Please coated balloon
Angioplasty with Drug coated balloon (DCB)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ischemic symptoms (angina pectoris) \> 30 minutes
* Last symptoms within 72 hours before randomization
* Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
* age \> 18 years
* Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)
Exclusion Criteria
* ST-elevation myocardial infarction
* No identifiable culprit lesion, Indication for acute bypass surgery
* Comorbidity with limited life expectancy \< 9-12 months
* Contraindication for treatment with heparin, ASA and thienopyridines
18 Years
ALL
No
Sponsors
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University Hospital, Saarland
OTHER
Responsible Party
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Principal Investigators
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Bruno Scheller, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Locations
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Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg/Saar, Saarland, Germany
Countries
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Other Identifiers
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PEPCAD NSTEMI
Identifier Type: -
Identifier Source: org_study_id
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